Director, Biostatistics

We are seeking a Director of Biostatistics. In this position you will function as the statistical lead for one or more studies, providing technical leadership and statistical support on the design, conduct and execution of the clinical studies. You will partner closely with the cross-functional teams and provide expert biostatistics input on development plans, regulatory interactions, and study design. This may include but is not limited to authoring/review of statistics section in the protocol, sample size determination, authoring/review of statistical analysis plan and mock TFL, reviewing study randomization files, ADaM specs, CRF design, DMC charter, analyzing and interpreting the clinical study results, and ensuring statistical integrity.

Key Responsibilities

• Key contributor on regulatory submissions and communication with global regulatory authorities
• Provide expert statistical advice, methodological research, and analysis of trial and epidemiological data to inform the design, planning, and execution of Apogee’s clinical studies
• Review and/or author statistical analysis sections of protocols, statistical analysis plans, clinical study reports, regulatory documents, or scientific publications, generates or reviews study randomization, and sample size/power estimations
• Oversee the vendor/CRO biostatistics teams, including activities during TFL development, Data Monitoring Safety Board meetings, interim analyses, and database locks
• Execute or oversee individual projects, which will include meeting with project/study team members, conducting exploratory analyses and graphic support, and providing analyses for publications of Apogee’s studies
• Evaluate alternative or innovative approaches to statistical methods and study design
• Build relationships with CROs and other external partners to achieve results for specific project needs
• Ensure the delivery of high quality and timely reports to project teams and clinical trial team

Ideal Candidate

• PhD in statistics strongly preferred; Candidates with MS in statistics or biostatistics and a depth of relevant experience in drug development statistical research will be considered
• A minimum of 10 years’ experience in progressive and relevant clinical trial experience
• Advanced knowledge of statistical methods in clinical study designs (including adaptive designs, Bayesian methods, and platform trials), statistical analysis methods (such as Bayesian analysis, missing data imputation, and multiplicity adjustment with graphical approaches), and expertise in analyzing continuous, binary, count, and time-to-event data
• Strong experience in designing, executing, analyzing, and interpreting simulations, including clinical trial simulations
• Knowledge and proficiency in SAS or R and other industry computational tools
• Knowledge of CDISC standard including SDTM, ADaM
• Knowledge of ICH guidelines, FDA / EMA / other regulatory authority guidance
• Experience leading teams and working in a matrix organization
• Ability to communicate and collaborate directly with non-statisticians imparting and delivering complex statistical information to scientific development partners and researchers
• Excellent communication with an ability to present to a variety of stakeholders and tailor message accordingly
• Experience managing CROs and other data vendors
• Ability to keep pace in a fast-moving organization and navigate ambiguity
• Experience working with in a remote virtual environment
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Travel to company meetings, conferences, etc. at least 4 – 8 times per year is required

The anticipated salary range for candidates for this role will be $230,000 to $250,000/year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.